cobas® EGFR Mutation Test v2

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> EGFR Mutation Test v2

The cobas® EGFR Mutation Test v2 is a real-time polymerase chain reaction (PCR) test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistance mutation.1

The cobas® EGFR Mutation Test v2 has been clinically validated in multiple clinical trials as a companion diagnostic (CDx) for both 1st and 2nd line EGFR tyrosine kinase inhibitors (TKI) therapy in patients with advanced non-small cell lung cancer [NSCLC).2 The exceptional robustness and repeatability of the cobas® EGFR Mutation Test v2 has been demonstrated in real-world intra and inter-laboratory studies,3 providing high confidence for labs in using the test.

It is designed to enable fast time-to-results testing of both tissue and plasma specimens simultaneously with a single kit (tissue results < 8 hrs, plasma results < 4 hrs).

For optimized workflow results, Roche has developed the cobas® DNA Sample Preparation Kit for DNA extraction from formalin-fixed paraffin-embedded tissue (FFPET) and the cobas® cfDNA Sample Preparation Kit for extraction of DNA from plasma.


  1. cobas EGFR Mutation Test package insert
  2. Heeke S et al, Clinical Lung Cancer 2019,
  3. Keppens C et al, J Mol Diagnostics 2018,


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